Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002652161 Date of Approval: 29/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Therapeutic Effectiveness and Safety of Locally Compounded, and some over the Counter Topical Analgesics in the Management of Neuropathic
Official scientific title Comparative Therapeutic Effectiveness and Safety of Locally Compounded, and some over the Counter Topical Analgesics in the Management of Neuropathic Pain
Brief summary describing the background and objectives of the trial Pain with neuropathic characteristics is generally more severe, and is associated with worse health, in every measured dimension compared to non-neuropathic pain. Currently, medications for the treatment of neuropathic pain (NP) are mostly systemic and are dose limited because of serious and debilitating adverse effects. Scientific evidence suggests that localized cutaneous NP can be treated effectively and safely using topical medications. Therefore this study will compare the therapeutic effectiveness of a locally compounded topical analgesic and some selected over the counter topical analgesics available in the Nigerian market in the management of NP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Neuropathic pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/10/2017
Actual trial start date 02/10/2017
Anticipated date of last follow up 02/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 27
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NASS/447/S/HREC/17/01
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nektisal A twicw a day four weeks Manual application of the ointment on the affected are of the body 8
Control Group Nektisal Z twice a day four weeks Manual application of the ointment on the affected are of the body 8 Dose Comparison
Experimental Group Neaurogesic cream twice a day four weeks Manual application of the ointment on the affected are of the body 8
Experimental Group Aboniki ointment twice a day four weeks Manual application of the ointment on the affected are of the body 8
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Being diagnosed of NP of any cause ¿ 18 years of age having signed an informed consent form History of sensory impairment Not residing in Abuja Presence of mental instability Having history of dementia 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/09/2017 National Assembly Clinic Human Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Three Arm Zone Abuja 900211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Base line (pre-intervention) Time 1 (two weeks of intervention) Time 2 (Post-intervention
Secondary Outcome safety profile one day after the last session of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Assembly Clinic NASS Complex, three arm zone Abuja 900211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Pharmaceutical Services, NASS Clinic three arm zone Abuja 900211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Pharmaceutical Services, NASS Clinic three arm zone Abuja 900211 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Joh Alfa three arm zone Abuja 900211 Nigeria
Bishir Atiku three arm zone Abuja 900211 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rabiu Ibrahim tok2rabs@gmail.com +2348188763871 three arm zone
City Postal code Country Position/Affiliation
abuja 900211 Nigeria AD Physiotherapist
Role Name Email Phone Street address
Public Enquiries Bishir Attiku basharuattiku@gmail.com +2348035044875 no 1 Ikot Ekpene close, off Emeka Anyuoku street
City Postal code Country Position/Affiliation
FCT, Abuja 900211 Nigeria Chief Pharmacist
Role Name Email Phone Street address
Scientific Enquiries John Alfa one2alfa@gmail.com +2348036548373 three arm zone
City Postal code Country Position/Affiliation
abuja 900211 Nigeria D. Pharmaceutical Services
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information